Lyme DiseasePEMFNCT04577053
PEMF Therapy to Treat Lingering Symptoms of Lyme Disease After Treatment With Antibiotics
A study testing Scientific Consciousness Interface Operations (SCIO) Class II FDA approved medical device in people with Lyme Disease and Lyme Neuroborreliosis, run by Kasey Phifer at 2 sites in United Kingdom.
Trial summary
Overview PEMF Therapy for relief or reduction of lingering symptoms after antibiotic treatment of Lyme disease of participants in the UK. Symptoms monitored: Muscle ache, myalgia, muscle pain that is acutely located and/or 'wandering' (different location on different days) Aching joints Headache Fatigue, general… Read more about this study
- Who is it for?
- Ages 14 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lyme Disease, Lyme Neuroborreliosis, Lyme Arthritis
- What is being tested?
- Scientific Consciousness Interface Operations (SCIO) Class II FDA approved medical device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 7 Oct 2020to 28 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Diagnosis from GP confirming Lyme disease and/or
- Blood test confirming Lyme disease and/or
- Symptoms that correlate to Lyme disease without diagnosis from GP. This is called "self diagnosis" and because 80% of the trial is focused on treating symptoms and not the spirochetes, bacteria or small cysts of Lyme disease, the results are expected to be largely the same
Who cannot join
- Persons currently undergoing antibiotic treatment for Lyme or other conditions
- Persons who were prescribed antibiotics but did not or could not take them
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
The Bristol Centre for Biofeedback
Bristol, BS8 1LR
The National Centre for Electromagnetic Therapies CIC
Weston, BS24 9AY
About this study
Official title: Pulsed ElectroMagnetic Field Therapy With Square Wave Forms and Artificial Intelligence Within the Software Interface for Individualised, Bespoke Bio-Electromagnetic Therapy to Treat Symptoms of Chronic Lyme Disease Remaining After Antibiotics Treatment
Overview
PEMF Therapy for relief or reduction of lingering symptoms after antibiotic treatment of Lyme disease of participants in the UK.
Symptoms monitored:
Muscle ache, myalgia, muscle pain that is acutely located and/or 'wandering' (different location on different days) Aching joints Headache Fatigue, general tiredness, loss of energy, general exhaustion Mild, recurrent fever and/or chills occurring regularly Lack of oxygen in blood, feelings of 'air hunger', too high carbon dioxide levels in blood
Read the detailed description
Hypothesis Period measured and observed: 18 months (Includes before treatment, during the 4-8 weeks of treatment and post treatment)
Control Group Control Group symptoms will remain the same or increase (deteriorate or worsen) by 10-20% over the period observed.
The Control Group is not asked to nor required to abstain from any other forms of treatment during the 10 month observational period; Persons in the Control Group are free to - but not encouraged to - pursue holistic, complementary and mainstream medicine for their symptoms related to contraction of Lyme Disease and any other illness that may arise.
In the event of receiving treatment or taking medicine, this information is to be passed along for data collection in the regular surveys. This will be taken into consideration when evaluating the results of the trial and hypothesis.
Test Group Test Group symptoms will improve (be reduced or eliminated) by 50-75% over the period observed; In particular, the largest improvement will be achieved during the 8 weeks of treatment. After treatment, there may be a slight improvement of symptoms, however, the improvement achieved during treatment is expected to remain the same over the next 7.5 months following treatment with the exception of re-infection or contraction of a different disease or illness.
The Test Group is not asked to nor required to abstain from any other forms of treatment during the 10 month observational period; Persons in the Control Group are free to - but not encouraged to - pursue holistic, complementary and mainstream medicine for their symptoms related to contraction of Lyme Disease and any other illness that may arise.
In the event of receiving treatment or taking medicine, this information is to be passed along for data collection in the regular surveys. This will be taken into consideration when evaluating the results of the trial and hypothesis.
Measurement (What the Investigator is Measuring and Observing in Response to Testing) and Weighting
Measurement: 1 to 100 Scale Worsening/decline or improvement/reduction of symptoms will be measured by the information collected in the surveys. Answers to questions are given subjectively by the participants themselves on a scale of 1 to 100, with 1 being the worst possible or imaginable and 100 being the best possible or imaginable. For example, the worst imaginable answer of "1" to the question of mobility/movement would be in the event that the participant is in a wheelchair or coma. Being confined to a wheelchair is certainly more mobile than lying in a comatose state, however, the answers to each question are subjective and so the participant might believe that a wheelchair would be the worst measure of mobility for him or her.
Weighting of Answers To weight the improvement or decline respectively for each participant, the average of the first three and last three surveys will be taken. This is to rule out any possible statistical outliers or anomalies due to the participant possibly having a 'bad day' or coincidental other illness such as a head cold.
Example Question:
Rate overall energy level on a scale of 1 to 100, where 1 is the lowest imaginable and 100 is the best, pre-Lyme Disease level possible.
Example Answers:
Participant A First survey: 45 Second survey: 40 Third survey: 48 25th survey (third to last): 80 26th survey (second to last): 83 27th survey (last or final): 80
Weighting here would be calculated in the following way:
Starting point or "zero point" is the average of the first three surveys
- ( 45 + 40 + 48 ) / 3 = 44.33 Ending point is the average of the last three surveys
- ( 80 + 83 + 80 ) / 3 = 81 An improvement of 100% for this participant would be from 44.33 at the starting point up to 100 at the ending point, what is to be considered a full recovery or full elimination of symptoms. The breadth of full recovery therefore contains a different amount of scala numbers for each participant, because a full recovery is based individually on each participant. This is to avoid an increase or decrease of more than 100%.
Using this example:
No improvement would be from 44.33 to [44-44.49], an increase of approximately 0 = 0% Full recovery would be from 44.33 to 100, an increase of 55.67 = 100% Amount of improvement in the example is from 44.33 to 81, an increase of 36.67; It is then calculated 36.67 / 55.67 = 68.9%
Participant B (Example Answers) First survey: 30 Second survey: 25 Third survey: 25 25th survey (third to last): 80 26th survey (second to last): 83 27th survey (last or final): 80
Weighting here would be calculated in the following way:
Starting point or "zero point" is the average of the first three surveys
- ( 30 + 25 + 25 ) / 3 = 26.67 Ending point is the average of the last three surveys
- ( 80 + 83 + 80 ) / 3 = 81 An improvement of 100% for this participant would be from 26.67 at the starting point up to 100 at the ending point, what is to be considered a full recovery or full elimination of symptoms.
Using this example:
No improvement would be from 26.67 to [26.5-27], an increase of approximately 0 = 0% Full recovery would be from 26.67 to 100, an increase of 73.33 = 100% Amount of improvement in the example is from 26.67 to 81, an increase of 54.33; It is then calculated 54.33 / 73.33 = 74.1%
More information can be found published on the investigator's website: https://biofeedbackcentrebristol.co.uk/lyme-disease-clinical-trial/
- Being tested
- Scientific Consciousness Interface Operations (SCIO) Class II FDA approved medical device
- Medical subject headings
- Lyme Disease, Lyme Neuroborreliosis, Fever of Unknown Origin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scientific Consciousness Interface Operations (SCIO) Class II FDA approved medical deviceDevice
Also called INDIGO, QXCI, QUEX S, QUEX ED
Manufactured by QX World Ltd. in Budapest, Hungary
| Study group | Role | What they receive |
|---|---|---|
| PEMF Therapy | Experimental | Pulsed ElectroMagnetic Field Therapy using square wave forms. In addition to set, pre-defined frequencies to aid the body's own immune system, the Artificial Intelligence incorporated into the software used will suggest a variety of frequencies to be administered during treatment. Due to the software's selection, these recommendations or selections from the software will likely be different in each treatment session. Receives: Device: Scientific Consciousness Interface Operations (SCIO) Class II FDA approved medical device |
| Control | No intervention | Control group will not receive treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Energy Levels
This is inversely describing fatigue, chronic fatigue and exhaustion which is a common symptom of Lyme Disease.
Measured: 18 months
Myalgia
This will be described to participants in an easy-to-understand 'layman' terminology. Words here include e.g. muscle ache, soreness of muscles.
Measured: 18 months
Joint stiffness
Stiffness, soreness and lack of range of motion in any and all joints
Measured: 18 months
Depression
This is measuring the participant's own subjective feelings of mood and depression, not a clinical diagnosis.
Measured: 18 months
Fever/Chills
mild, recurrent fever is a common symptom of Lyme Disease. Temperature will be measured by the participants themselves should they suffer from this.
Measured: 18 months
Secondary outcomes (4)
Ability to Breathe
'Air Hunger' or the feeling of not getting enough oxygen when breathing
Measured: 18 months
Encephalitis
Inflammation of the brain and/or spinal cord measured using the scan built into the software to confirm whether any is present in absence of medical diagnosis. Patients will report on symptoms of encephalitis, i.e. confusion, seizures, difficulty speaking, sudden changes in behaviour
Measured: 18 months
Brain Fog
This is most likely due to hormone imbalance which results in depression, insomnia, confusion and other symptoms.
Measured: 18 months
Nerve pain / damage
damage to the nerves resulting in loss of fine or gross motor skills, shooting pains along nerves
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2020
- Study start7 Oct 2020
- Primary completion4 Dec 2020
- Study completion28 Sep 2021
Why it stopped: It was discovered during the study that Lyme Disease is a bio warfare weapon made in USA. (See "Bitten" by Kris Newby.) The second reason for stopping the study is lack of participant responses, likely due to lack of payment for completing surveys.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lyme DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Control group and treatment group, no placebo
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasey Phifer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kasey Phifer, The National Centre for ElectroMagnetic Therapies CIC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04577053
- Sponsor's protocol ID
- PEMF-BRI-Lyme-Disease-2020
- Other IDs
- Bioresonance Biofeedback
- Acronym
- PEMF
- Status last verified
- Apr 2022
- First submitted
- 17 Sep 2020
- Last updated
- 13 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Via spreadsheet and cloud sharing
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulsed ElectroMagnetic Field Therapy With Square Wave Forms and Artificial Intelligence Within the Software Interface for Individualised, Bespoke Bio-Electromagnetic Therapy to Treat Symptoms of Chronic Lyme Disease Remaining After Antibiotics Treatment
- ClinicalTrials.gov ID
- NCT04577053
- Acronym / sponsor ID
- PEMF / PEMF-BRI-Lyme-Disease-2020
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: It was discovered during the study that Lyme Disease is a bio warfare weapon made in USA. (See "Bitten" by Kris Newby.) The second reason for stopping the study is lack of participant responses, likely due to lack of payment for completing surveys.
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Kasey PhiferUniversity, hospital or other
- Study start
- 7 Oct 2020 (actual)
- Primary completion
- 4 Dec 2020 (actual)
- Study completion
- 28 Sep 2021 (actual)
- First posted
- 6 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Overview
PEMF Therapy for relief or reduction of lingering symptoms after antibiotic treatment of Lyme disease of participants in the UK.
Symptoms monitored:
Muscle ache, myalgia, muscle pain that is acutely located and/or 'wandering' (different location on different days) Aching joints Headache Fatigue, general tiredness, loss of energy, general exhaustion Mild, recurrent fever and/or chills occurring regularly Lack of oxygen in blood, feelings of 'air hunger', too high carbon dioxide levels in blood
Detailed description
Hypothesis Period measured and observed: 18 months (Includes before treatment, during the 4-8 weeks of treatment and post treatment)
Control Group Control Group symptoms will remain the same or increase (deteriorate or worsen) by 10-20% over the period observed.
The Control Group is not asked to nor required to abstain from any other forms of treatment during the 10 month observational period; Persons in the Control Group are free to - but not encouraged to - pursue holistic, complementary and mainstream medicine for their symptoms related to contraction of Lyme Disease and any other illness that may arise.
In the event of receiving treatment or taking medicine, this information is to be passed along for data collection in the regular surveys. This will be taken into consideration when evaluating the results of the trial and hypothesis.
Test Group Test Group symptoms will improve (be reduced or eliminated) by 50-75% over the period observed; In particular, the largest improvement will be achieved during the 8 weeks of treatment. After treatment, there may be a slight improvement of symptoms, however, the improvement achieved during treatment is expected to remain the same over the next 7.5 months following treatment with the exception of re-infection or contraction of a different disease or illness.
The Test Group is not asked to nor required to abstain from any other forms of treatment during the 10 month observational period; Persons in the Control Group are free to - but not encouraged to - pursue holistic, complementary and mainstream medicine for their symptoms related to contraction of Lyme Disease and any other illness that may arise.
In the event of receiving treatment or taking medicine, this information is to be passed along for data collection in the regular surveys. This will be taken into consideration when evaluating the results of the trial and hypothesis.
Measurement (What the Investigator is Measuring and Observing in Response to Testing) and Weighting
Measurement: 1 to 100 Scale Worsening/decline or improvement/reduction of symptoms will be measured by the information collected in the surveys. Answers to questions are given subjectively by the participants themselves on a scale of 1 to 100, with 1 being the worst possible or imaginable and 100 being the best possible or imaginable. For example, the worst imaginable answer of "1" to the question of mobility/movement would be in the event that the participant is in a wheelchair or coma. Being confined to a wheelchair is certainly more mobile than lying in a comatose state, however, the answers to each question are subjective and so the participant might believe that a wheelchair would be the worst measure of mobility for him or her.
Weighting of Answers To weight the improvement or decline respectively for each participant, the average of the first three and last three surveys will be taken. This is to rule out any possible statistical outliers or anomalies due to the participant possibly having a 'bad day' or coincidental other illness such as a head cold.
Example Question:
Rate overall energy level on a scale of 1 to 100, where 1 is the lowest imaginable and 100 is the best, pre-Lyme Disease level possible.
Example Answers:
Participant A First survey: 45 Second survey: 40 Third survey: 48 25th survey (third to last): 80 26th survey (second to last): 83 27th survey (last or final): 80
Weighting here would be calculated in the following way:
Starting point or "zero point" is the average of the first three surveys
- ( 45 + 40 + 48 ) / 3 = 44.33 Ending point is the average of the last three surveys
- ( 80 + 83 + 80 ) / 3 = 81 An improvement of 100% for this participant would be from 44.33 at the starting point up to 100 at the ending point, what is to be considered a full recovery or full elimination of symptoms. The breadth of full recovery therefore contains a different amount of scala numbers for each participant, because a full recovery is based individually on each participant. This is to avoid an increase or decrease of more than 100%.
Using this example:
No improvement would be from 44.33 to [44-44.49], an increase of approximately 0 = 0% Full recovery would be from 44.33 to 100, an increase of 55.67 = 100% Amount of improvement in the example is from 44.33 to 81, an increase of 36.67; It is then calculated 36.67 / 55.67 = 68.9%
Participant B (Example Answers) First survey: 30 Second survey: 25 Third survey: 25 25th survey (third to last): 80 26th survey (second to last): 83 27th survey (last or final): 80
Weighting here would be calculated in the following way:
Starting point or "zero point" is the average of the first three surveys
- ( 30 + 25 + 25 ) / 3 = 26.67 Ending point is the average of the last three surveys
- ( 80 + 83 + 80 ) / 3 = 81 An improvement of 100% for this participant would be from 26.67 at the starting point up to 100 at the ending point, what is to be considered a full recovery or full elimination of symptoms.
Using this example:
No improvement would be from 26.67 to [26.5-27], an increase of approximately 0 = 0% Full recovery would be from 26.67 to 100, an increase of 73.33 = 100% Amount of improvement in the example is from 26.67 to 81, an increase of 54.33; It is then calculated 54.33 / 73.33 = 74.1%
More information can be found published on the investigator's website: https://biofeedbackcentrebristol.co.uk/lyme-disease-clinical-trial/
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Control group and treatment group, no placebo
| Arm | Type | Receives |
|---|---|---|
| PEMF Therapy | Experimental | Device: Scientific Consciousness Interface Operations (SCIO) Class II FDA approved medical devicePulsed ElectroMagnetic Field Therapy using square wave forms. In addition to set, pre-defined frequencies to aid the body's own immune system, the Artificial Intelligence incorporated into the software used will suggest a variety of frequencies to be administered during treatment. Due to the software's selection, these recommendations or selections from the software will likely be different in each treatment session. |
| Control | No intervention | –Control group will not receive treatment. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis from GP confirming Lyme disease and/or
- Blood test confirming Lyme disease and/or
- Symptoms that correlate to Lyme disease without diagnosis from GP. This is called "self diagnosis" and because 80% of the trial is focused on treating symptoms and not the spirochetes, bacteria or small cysts of Lyme disease, the results are expected to be largely the same
Key exclusion criteria (2 listed)
- Persons currently undergoing antibiotic treatment for Lyme or other conditions
- Persons who were prescribed antibiotics but did not or could not take them
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scientific Consciousness Interface Operations (SCIO) Class II FDA approved medical deviceAlso: INDIGO, QXCI, QUEX S, QUEX EDManufactured by QX World Ltd. in Budapest, Hungary | Device | PEMF Therapy |
Primary outcome
Overall Energy Levels
Time frame: 18 months
This is inversely describing fatigue, chronic fatigue and exhaustion which is a common symptom of Lyme Disease.
Myalgia
Time frame: 18 months
This will be described to participants in an easy-to-understand 'layman' terminology. Words here include e.g. muscle ache, soreness of muscles.
Joint stiffness
Time frame: 18 months
Stiffness, soreness and lack of range of motion in any and all joints
Depression
Time frame: 18 months
This is measuring the participant's own subjective feelings of mood and depression, not a clinical diagnosis.
Fever/Chills
Time frame: 18 months
mild, recurrent fever is a common symptom of Lyme Disease. Temperature will be measured by the participants themselves should they suffer from this.
4 secondary outcomes
Ability to Breathe
Time frame: 18 months
Encephalitis
Time frame: 18 months
Brain Fog
Time frame: 18 months
Nerve pain / damage
Time frame: 18 months
Results and safety
The study was stopped early (reason given: It was discovered during the study that Lyme Disease is a bio warfare weapon made in USA. (See "Bitten" by Kris Newby.) The second reason for stopping the study is lack of participant responses, likely due to lack of payment for completing surveys.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2022.
- Investigator websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Via spreadsheet and cloud sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scientific Consciousness Interface Operations (SCIO) Class II FDA approved medical device in people with Lyme Disease and Lyme Neuroborreliosis, run by Kasey Phifer at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: It was discovered during the study that Lyme Disease is a bio warfare weapon made in USA. (See "Bitten" by Kris Newby.) The second reason for stopping the study is lack of participant responses, likely due to lack of payment for completing surveys.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Energy Levels (time frame: 18 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2022.